Wednesday, May 20, 2009

Health-care fraud is among the top enforcement priorities of the new team at the Justice Department, which is working closely with the inspector general at HHS and the FBI to collect and analyze computerized information about fraudulent claims.

As part of the effort, authorities this afternoon launched a new task force, the Health Care Enforcement Action Team, to be led by senior officials at Justice and HHS.

"With this announcement, we raise the stakes on health-care fraud," Holder said.

Trade groups estimate that as much as 3 percent of health-care spending, or $60 billion, is lost to fraud each year.

Saturday, May 16, 2009

In the eleventh hour of its legislative session Friday night, Vermont passed a bill that would:

-ban most gifts to physicians,-lift the trade secrets exemption in Vermont’s current gifts disclosure and transparency law,-extend it to medical device manufacturers, create a public website to house the information, and-broaden the type of payment recipients that companies would be required to disclose.

Friday, May 15, 2009

President Obama announced on Friday that he has chosen Dr. Thomas R. Frieden, the New York City health commissioner, as the next director of the Centers for Disease Control and Prevention....At the C.D.C., he will inherit a host of immediate and long-term problems, including a looming decision about whether and how to produce a swine flu vaccine. Health experts say the agency must resolve serious morale and organizational issues even as the administration struggles to overhaul the nation’s health care system....Dr. Frieden has a history of focusing on health threats that endanger large numbers of people, sometimes at the expense of more popular causes.

Wednesday, May 13, 2009

The FDA issued a warning letter to Ken Powell, Chairman of the Board and CEO of General Mills relative to the "the label and labeling" of Cheerios® Toasted Whole Grain Oat Cereal. From the letter:

FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR)....Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.

A first-time entrant, MedPage Today took the top spot and earned the Gold Award in the ASHPE competition's Online Category. A panel of well-respected business journalists and academics judged the entries against the publication's mission, the relevance to the category for which it was being considered, and its significance to the publication's target audience.

Wednesday, May 06, 2009

Big Pharma won't escape from Sen. Charles Grassley's eagle eye yet. Rather than slipping into newly Democratic Sen. Arlen Specter's seat on the Senate Judiciary Committee, Grassley made a deal to postpone his move until the next Congress launches in 2011, the New York Times reports. In the meantime, the ranking Republic on Judiciary will be Sen. Jeff Sessions--and Grassley will stay firmly fixed on the Finance Committee, the better to influence healthcare reform and follow through on his pharma-oversight initiatives.

Tuesday, May 05, 2009

Clear communication is a cornerstone of patient safety and quality health care. Quality translated health materials can serve as valuable communications tools for both patients and providers, and can help to ensure the delivery of safe, effective and high-quality care.

The More Than Words Toolkit Series, a resource developed by Hablamos Juntos with support from the Robert Wood Johnson Foundation, clarifies the translation process and provides a roadmap to help health care organizations improve the quality of their translated materials in order to get better results.

The More than Words Toolkit Series draws on the scientific literature, the experience of 10 Hablamos Juntos demonstrations and the initiative’s own research on translation quality. It is designed to assist individuals and organizations in initiating translations of health care text of all types.

For organizations that need to assess the quality of translated materials, users can find professionals who can rate materials based on the Translation Quality Assessment (TQA) tool.

Friday, May 01, 2009

Dancing in the streets yet? If you're not, then you haven't heard that Sen. Charles Grassley, the perpetual thorn in pharma's side, looks to be stepping down from his post as chief of the Senate Finance Committee. He's planning to move to Senate Judiciary instead, where the top Republican post was abandoned by Sen. Arlen Specter, a newly minted Democrat.

If the word on Grassley is true, then pharma may be able to say sayonara to the steady flow of letters from Grassley, who demanded answers on a plethora of industry issues, from drugmakers' relationships with prominent doctors and academic researchers to a host of drug safety questions.